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Are Generics as Effective as Brand-Name Drugs?, from the Harvard Health Letter


2/16/2012 9:53:19 AM

BOSTON, MA—In the February issue of the Harvard Health Letter, Editor in Chief Dr. Anthony L. Komaroff answers a question that’s on a lot of people’s minds these days: is atorvastatin, the generic version of the cholesterol-lowering drug Lipitor, as good as the brand-name drug?

Generic atorvastatin became available for the first time in November 2011 after Lipitor lost its patent protection. In his answer, Dr. Komaroff notes that the FDA is legally required to determine that generics are “bioequivalent” to brand-name drugs, which means they produce similar blood concentrations of the same chemicals.

“Many independent researchers have also compared generics with brand-name drugs, and the vast majority of them have concluded that generics are just as safe and effective,” Dr. Komaroff says in the Health Letter, citing research by his Harvard colleague Dr. Aaron Kesselheim and others.

Generics are produced in other countries, and overseas manufacturers do make mistakes, Dr. Komaroff notes. “But that’s also true of U.S.-based manufacturers,” he continues. “The FDA does regulate the manufacture of all drugs sold in the United States, which is reassuring, but I also believe the FDA hasn’t been given the budget it needs to adequately carry out its responsibilities. So I can’t give you an absolute guarantee that generic atorvastatin will be equal to brand-name Lipitor.

“But I can tell you this: I take Lipitor, and I’ll be switching to generic atorvastatin, so I will be following my own advice (something my wife has suggested that I should do more often).”

Read the full-length article: “Ask the Doctor: Are generics as good as brand-name drugs?”

Also in the February 2012 issue of the Health Letter:

- Stop waiting: 3 things you can do for your health this month

- Answers to follow-up questions about the Healthy Eating Plate, a Harvard guide to healthful eating

- The medications most likely to cause emergency hospitalizations among older people — and suggestions for keeping it from happening

- What is a tailor’s bunion?

- An interview with Dr. Lynne Warner Stevenson, a heart failure specialist at Harvard-affiliated Brigham and Women’s Hospital

- Are diabetes and sleep apnea connected?

The Harvard Health Letter is available from Harvard Health Publications, the publishing division of Harvard Medical School, for $29 per year. Subscribe at www.health.harvard.edu/health or by calling 877-649-9457 (toll-free).



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